Overview

Study of NAC of GA Therapy for Patients With BRPC

Status:
Unknown status
Trial end date:
2021-09-01
Target enrollment:
0
Participant gender:
All
Summary
Gemcitabine plus nub-paclitaxel (GA) regimen was recently presented at an international oncology meeting and represents a new standard regimen in the treatment of metastatic pancreatic cancer. Therefore, it was decided to consider the balance of safety and efficacy on survival time as a preoperative chemotherapy, the investigators use the NAC-GA regimen includes only two cycles (three times weekly and one week rest) of GA regimen.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Wakayama Medical University
Treatments:
Albumin-Bound Paclitaxel
Gemcitabine
Paclitaxel
Criteria
Inclusion Criteria:

1. Histologically or cytologically diagnosed as pancreatic adenocarcinoma, and consistent
with NCCN guideline (Version 2. 2016) borderline resectable-arterial, borderline
resectable-venous

2. Case with measurable lesion

3. First line treatment

4. PS (ECOG) 0-1

5. >= 20 years old and <80 years old

6. The following criteria must be satisfied in laboratory tests within 14 days of
registration

- WBC count<=12,000/mm3

- Neutrophil count>=1,500/mm3

- Hb >= 9.0g/dl

- Plt >= 100,000/mm3

- T.Bil <2.0mg/dl (<3=.0mg/dl in biliary drainage case)

- Serum Cr<=upper limits of normal (ULN)

- AST, ALT <= 2.5xULN

7. Written informed consent to participate in this study

Exclusion Criteria:

1. Severe drug hypersensitivity

2. Multiple primary cancers within 5 years

3. Severe infection

4. With grade2 or more severe peripheral neuropathy

5. Interstitial pneumonia or pulmonary fibrosis

6. With uncontrollable pleural effusion or ascites

7. With uncontrollable diabetes mellitus

8. With uncontrollable heart failure, angina, hypertension, arrhythmia

9. With severe neurological/psychological symptoms

10. With watery diarrhea

11. Pregnant or lactating women or women with unknown or suspected pregnancy

12. Inappropriate patients for entry on this study in the judgement of the investigator

13. Diagnosed as Resectable/Unresectable pancreatic carcinoma on NCCN guideline (Version
2.2016)